This invention relates to the field of blood screening and provides improvements that enable more comprehensive, accurate and convenient screening to be performed, for detecting the presence of targeted molecules that indicate the presence of a pathogen, infectious agent or metabolic disease. More specifically, the invention provides a method and system for in-line blood screening, wherein an in-line removable screening capture device with biochips is provided between a blood collection needle and a blood collection bag, such that collected blood flows through the screening capture device and contacts the biochips before being collected in the blood collection bag. Alternatively, the biochips are provided in an inlet of the blood collection bag, inside the blood collection bag or inside a separate diversion blood collection bag.
Currently, blood banks use several individual assays to test for the presence of multiple agents or molecules associated with or indicative of a disease or condition. Exemplary agents or molecules include anti-HIV I/II antibodies, anti-HCV antibodies, HBV surface antigen, anti-HBC antibodies, liver enzyme (ALT), syphilis and HIV P24 antigen. Additionally, infectious agents such as pathogenic bacteria and fungi, prions and protozoa, including the causative agents of small pox, malaria, West Nile disease, Chagas disease, and variant Creutzfel Jacob disease (CJD) may be detected. Also, non-infectious agents such as molecules that indicate metabolic disorders, including the molecules measured in various metabolite panels, may be detected, including a lipid panel (cholesterol, triglycerides, LDLs and HDLs), thyroid hormone panel (T3, T4, TBP and TSH) and liver enzyme panel (ALT (alanine aminotransferase), ALP (alkaline phosphatase), AST (aspartate aminotransferase), GGT (gamma-glutamyl transferase), LDH (lactic acid dehydrogenase), bilirubin, and albumin).
The current methods involve collecting blood directly into a blood collection bag via a collection needle and collecting duct, with a very minute fraction of the collected blood being segregated into another compartment for testing/screening purposes. Current methods of blood screening, therefore, involve testing a very small portion, or sample, of the collected blood and may not effectively detect analytes that are sparsely dispersed in the blood. Some potential problems of testing small samples include (1) non-homogeneous distribution of the testing agent (or analyte), (2) micro-aggregation of the analytes and/or binding of the analytes to serum proteins, and (3) cross-contamination between samples taken for the various tests that may be conducted, such as in the nucleic acid technology assays (NAT).
Furthermore, performing multiple individual assays requires duplicative time and effort because the sample must be prepared and labeled for each individual assay. Additionally, the performance of multiple individual assays compounds the problem of appropriately labeling and tracking blood samples so that they can be correlated to the correct patient or donor. Errors and inaccuracies therefore can result from clerical errors in labeling, correlating and storing information generated from the multiple individual assays. Another problem is that too much blood may be used for testing because a separate sample is required for each of the various tests to be conducted.
Additionally, separating a collected blood sample into portions for multiple individual assays increases the potential for contamination, due to the additional handling required. Of course, the conduct of multiple individual assays also increases the risk that at least one assay will corrupted by contamination.